A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD)

In the opinion of the Investigator, the participant has a significant risk for suicidal behavior during the course of her/his participation in the study or is considered to be an imminent danger to her/himself or others, and/or: a. At baseline, the participant scores "yes" on suicidal Ideation Items 4 or 5 of the Columbia-suicide severity rating scale (C-SSRS) "Since Last Visit" version; b. At baseline, the participant scores \>= 5 on the Montgomery-Asberg depression rating scale (MADRS) Item 10 (suicidal Thoughts); c. The participant is considered to be an imminent danger to themself or others based on the assessment of the Investigator

The participant is breast-feeding or pregnant; female participants of childbearing potential must have a negative urine pregnancy test at baseline

Based on the Investigator's clinical judgement, any abnormal clinical laboratory test or electrocardiogram (ECG) results obtained throughout the lead-in study that are considered clinically significant and preclude safe participation in the study

The participant has any other condition that may be detrimental to the participant if they participate in the study

In the opinion of the Investigator, the participant is unable to comply with study procedures or judged to be inappropriate for the study

Within the participant's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses: a. schizophrenia, schizoaffective disorder, schizophreniform disorder or other psychotic disorder; b. bipolar disorder

Within 6 months of screening, has a confirmed DSM-5-TR psychiatric diagnosis other than GAD, including: a. other anxiety disorders; b. moderate or severe alcohol or substance use disorders; c. moderate or severe major depressive disorder (MDD)

MADRS total score greater than (\>) 18 at screening or baseline

The participant has received electroconvulsive therapy (ECT) or vagal nerve stimulation within the past 5 years, or repetitive trans cranial magnetic stimulation within the last 2 years, or had a failure in response to ECT at any time

The participant has known hypersensitivity or intolerance to ITI-007 (lumateperone), ITI-1284, or to any of the excipients

What this study is about